Federal control substance act Flashcards
Who should register with the DEA?
Manufacturers if they make CS or compounding pharmacies that deal with CS.
Distributors (wholesalers)
Dispensers (Pharmacies)
What is a form 223a?
It is a form to request reprints of lost DEA licenses
What is the form usually hung up on the wall in pharmacies?
form 223
What is a form 224?
It is to apply for a DEA license for pharmacies and you can use it to renew
What is a form 225?
It is a DEA license registration form for manufacturers or researchers. This could include pharmacists, just not in the dispensing role.
What is a form 363?
It is a DEA license registration form for narcotic treatment programs
When do DEA licenses expire?
36 months after last renewal.
It expires on the last day of the month
Can you do anything with an expired DEA license?
No
How long is the late license renewal for a DEA license?
30 days. After that, a new application must be completed
If you are moving, when should the DEA approve of the change of address?
PRIOR to the move.
A new DEA license will be issued. Both old and new licenses must be kept until a completed renewal cycle.
What do you do with your DEA license when it is expired?
Return the DEA license and any form 222s left.
When should you notify the DEA if you are transferring business?
Registrant must notify the DEA at least 14 days in advance
What should be documented in a transfer of business?
Registrant notifies Special agent in charge.
Name, address, registration number, and auth business activity of BOTH transferor and transferee.
Current address or other.
Date controlled substances will be transferred.
If C2s are involved, completed DEA 222s must be filed for EACH med transferred
When is DEA registration not needed?
Warehouses as long as it’s only used for storage.
Practitioner’s office (if drugs are not stored there)
Common carriers
What requires separate DEA registration?
Manufacturing CS
Distributing CS
Dispensing CII-IV
Research with CI-V
Narcotic treatment program for CII-V
Importing and exporting CS
Conducting chemical analysis of CS
What officials are exempt from getting a DEA license?
1) Military physicians (they use service ID and branch)
2) Physicians in training
3) Law enforcement
4) End user
5) During times of crisis or emergency
Is registration with DEA required for Scheduled listed chemical products (SLCPs)?
No, BUT they must self-certify that they meet the requirements with the feds to sell these
What must a pharmacy do if they want to sell bulk quantities of SLCPs?
They must register as a chemical distributor
Who schedules medications?
The DEA
What may a state do to the level of a schedule?
They may INCREASE the level. but they can not decrease it.
What are schedule I drugs?
High potential for abuse.
No current accepted medical use.
Lack safety data.
What are the noted schedule I drugs?
GHB
Heroin
Lysergic acid diethylamide (LSD)
Mescaline (Peyote)
Marijuana (Pot)
Methaqualone (Quaaludes)
Methcathinone
What are schedule II drugs?
Have a high potential for abuse.
Have an accepted medical use.
Abuse may lead to severe physical or psychological dependence.
What are the noted schedule II drugs?
1) Opiates or opioids (Codeine, HC, Methadone, Oxy)
2) Stimulants (Amphetamine, cocaine)
3) Depressants (Pentobarbital, Secobarbital)
4) Hallucinogens (Phencyclidine-PCP)
What are schedule III drugs?
Have a potential for abuse less than CI or CII.
Have a medical use.
Abuse may lead to moderate or low physical dependence or high psych depensdence.
What are the noted schedule III drugs?
1) APAP w/ codeine
2) Anabolic steroids
3) Buprenorphine
4) Butalbital w/ ASA
What are the schedule IV drugs?
Have low potential for abuse compared to CIII.
Current medical use.
What are the noted schedule IV drugs?
1) Alprazolam, Flurazapam, Clonazepam, Diazepam
2) Eszopiclone
4) Tramadol
What are the schedule V drugs?
1) Diphenoxylate/atropine (Lomotil)
2) 200 mg codeine per 100 ml
3) Pregabalin
4) Promethazine w/ codeine
What are examples of SLCPs?
Any product that contains ephedrine, pseudoephedrine, and phenylpropanolamine
Who decides which medication should be scheduled?
UN convention of psychotropic substances passes rule.
Secretary of health and human services.
Attorney general decides approval.
What factors are considered for substances to be scheduled?
Actual potential for abuse.
Scientific evidence of its pharmacological effect
Current scientific knowledge
History or pattern of abuse
Scope, duration, and significance
Psychic or physiological dependence
Is it already controlled?
How long is an emergency scheduling?
It’s good for one year.
If under investigation, extension for 6 months.
Attorney general can limit to schedule I only.
What form do you need to purchase or transfer a CI or CII?
DEA 222
Who can obtain a DEA 222?
Only CI or CII registered people
What is required to reorder more DEA 222 forms?
DEA 222a
Should be filled out by anything that cannot be altered.